Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
Patients on chronic stimulant therapy for the treatment of Attention deficit hyperactivity disorder (ADHD) who are undergoing an outpatient surgical or diagnostic procedure will be randomized to one of two groups: stimulant medication administered on the day of surgery or stimulant medication withheld on the day of surgery. The choice of anesthetic pharmacology will be at the discretion of the attending anesthesiologist, but the endpoint will be a bispectral index (BIS) between 40 and 60 to ensure adequate and similar depth of anesthesia. Blood pressure, heart rate and use of vasopressors or anticholinergics will be recorded and the incidence of hypotension, bradycardia, or administration of medications will be compared between the two groups.
Interventions
DRUGAmphetamine and/or methylphenidate
Patients who took their stimulant medication the day of surgery.
OTHERHold stimulant medication
Patients who held their stimulant medication the day of surgery.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients will be enrolled if they have been diagnosed with ADHD and have been taking amphetamines and/or methylphenidate for at least the last six months and are undergoing an outpatient surgical or diagnostic procedure.
Exclusion criteria
* Patients will be excluded if they are taking antidepressant medications, anxiolytic medication, analgesia medications other than acetaminophen or NSAIDs, if they have an allergy to midazolam, or a have cardiac disease. * Procedures that entail the likelihood of blood transfusion will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Day 1 | Heart rate prior to anesthetic induction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | Day 1 | Systolic blood pressure prior to anesthetic induction |
| Diastolic Blood Pressure | Day 1 | Diastolic blood pressure prior to anesthetic induction |
| Mean Blood Pressure | Day 1 | Mean blood pressure prior to anesthetic induction |
| mYPAS Measurement in Patients Receiving Midazolam | Day 1 | modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who received midazolam prior to anesthesia induction. Assessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = \[(A + V + E + S +U)/5\] x 100. Higher score = more anxiety. |
| mYPAS Measurement in Patients Not Receiving Midazolam | Day 1 | modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who did not receive midazolam prior to anesthesia induction. Assessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = \[(A + V + E + S +U)/5\] x 100. Higher score = more anxiety. |
Countries
United States
Participant flow
Pre-assignment details
Two subjects with unknown ADHD medication status were excluded from the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Patients Taking ADHD Medication Patients who took their amphetamine and/or methylphenidate the morning of surgery. | 14 |
| Patients Not Taking ADHD Medication Patients who held their stimulant medication the day of surgery. | 34 |
| Total | 48 |
Baseline characteristics
| Characteristic | Patients Taking ADHD Medication | Patients Not Taking ADHD Medication | Total |
|---|---|---|---|
| Age, Continuous | 9.25 years STANDARD_DEVIATION 2.56 | 9.35 years STANDARD_DEVIATION 2.79 | 9.32 years STANDARD_DEVIATION 2.7 |
| Sex: Female, Male Female | 3 Participants | 11 Participants | 14 Participants |
| Sex: Female, Male Male | 11 Participants | 23 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 34 |
| serious Total, serious adverse events | 0 / 14 | 0 / 34 |
Outcome results
Primary
Heart Rate
Heart rate prior to anesthetic induction
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Taking ADHD Medication | Heart Rate | 96.7 BPM | Standard Deviation 13.9 |
| Patients Not Taking ADHD Medication | Heart Rate | 88 BPM | Standard Deviation 14 |
Secondary
Diastolic Blood Pressure
Diastolic blood pressure prior to anesthetic induction
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Taking ADHD Medication | Diastolic Blood Pressure | 71.1 mmHg | Standard Deviation 11 |
| Patients Not Taking ADHD Medication | Diastolic Blood Pressure | 67.9 mmHg | Standard Deviation 9.3 |
Secondary
Mean Blood Pressure
Mean blood pressure prior to anesthetic induction
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Taking ADHD Medication | Mean Blood Pressure | 85.3 mmHg | Standard Deviation 10.5 |
| Patients Not Taking ADHD Medication | Mean Blood Pressure | 81.7 mmHg | Standard Deviation 8.6 |
Secondary
mYPAS Measurement in Patients Not Receiving Midazolam
modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who did not receive midazolam prior to anesthesia induction. Assessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = \[(A + V + E + S +U)/5\] x 100. Higher score = more anxiety.
Time frame: Day 1
Population: Of the 48 subjects analyzed, 38 subjects did not receive midazolam prior to their surgical procedure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Taking ADHD Medication | mYPAS Measurement in Patients Not Receiving Midazolam | 28 scores on a scale |
| Patients Not Taking ADHD Medication | mYPAS Measurement in Patients Not Receiving Midazolam | 28 scores on a scale |
Secondary
mYPAS Measurement in Patients Receiving Midazolam
modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who received midazolam prior to anesthesia induction. Assessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = \[(A + V + E + S +U)/5\] x 100. Higher score = more anxiety.
Time frame: Day 1
Population: Of the 48 subjects analyzed, 10 subjects received midazolam prior to their surgical procedure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Taking ADHD Medication | mYPAS Measurement in Patients Receiving Midazolam | 30 scores on a scale |
| Patients Not Taking ADHD Medication | mYPAS Measurement in Patients Receiving Midazolam | 26 scores on a scale |
Secondary
Systolic Blood Pressure
Systolic blood pressure prior to anesthetic induction
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Taking ADHD Medication | Systolic Blood Pressure | 113.6 mmHg | Standard Deviation 13.5 |
| Patients Not Taking ADHD Medication | Systolic Blood Pressure | 109.2 mmHg | Standard Deviation 12.4 |